MAUDE Adverse Event Report: IDEAL IMPLANT INCORPORATED IDEAL IMPLANT STRUCTURED BREAST IMPLANT; SALINE-FILLED BREAST IMPLANT

Model Number	67501
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Alleged deflation.
Event or Problem Description
Deflation resulting in explantation.
Additional Manufacturer Narrative
Deflation of the outer lumen due to a tear at the dome of the outer shell.There was no evidence of fatigue or instrument damage, so the cause of this tear could not be determined.No other defects were found on macroscopic or microscopic analysis of the implant.Update/correction to sections b1, b2, b4, b5, d6b, d9, g3, g6, h2, h3, h6 and h10.

• Brand Name: IDEAL IMPLANT STRUCTURED BREAST IMPLANT
• Common Device Name: SALINE-FILLED BREAST IMPLANT
• Manufacturer (Section D): IDEAL IMPLANT INCORPORATED; 14881 quorum drive; suite 925; dallas TX 75254
• MDR Report Key: 11668405
• Report Number: 3011491947-2021-00085
• Device Sequence Number: 11544438
• Product Code: FWM
• UDI-Device Identifier: 10851795006138
• UDI-Public: (01)10851795006138(241)67501(17)210328
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P120011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/28/2021
• Device Model Number: 67501
• Device Catalogue Number: 675
• Device Lot Number: 61936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 04/14/2021
• Supplement Report FDA Received Date: 08/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 33 YR